Trial Outcomes & Findings for WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer (NCT NCT01144442)
NCT ID: NCT01144442
Last Updated: 2019-07-30
Results Overview
We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.
TERMINATED
NA
10 participants
After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)
2019-07-30
Participant Flow
Women were recruited from the Women's Health Clinic at the University of Minnesota. Recruitment occurred from September 2010 to April 2012.
Once subjects signed consent, they underwent cytoreductive surgery by a gynecologic oncologist with intent to resect all visible cancer. If subjects did not achieve optimal cytoreduction, they were ineligible.
Participant milestones
| Measure |
HIPC Treatment
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer
Baseline characteristics by cohort
| Measure |
HIPC Treatment
n=10 Participants
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
|
56 years
FULL_RANGE 16.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.
Outcome measures
| Measure |
HIPC Treatment
n=10 Participants
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
|
|---|---|
|
Clinical Response
|
10 participants
|
PRIMARY outcome
Timeframe: 6 monthsWe will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.
Outcome measures
| Measure |
HIPC Treatment
n=10 Participants
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
|
|---|---|
|
Feasibility of HIPC in Recurrent Disease Setting
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27Population: Data was not collected due to the trial and all data collection processes being being terminated.
The quality of life measurements (version 4 of the FACT-O questionnaire) will be summed over each subscale and overall and comparisons will be made using t-tests at distinct visits.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 Years (intended)Population: Data was not collected due to the trial and all data collection processes being being terminated.
Disease progression will be defined as time from surgery to first of either an increase in CA125 from post-treatment value (to a value greater than 100 or doubling of nadir CA125 levels) or new/increasing measurable disease by CT scan as defined by RECIST criteria, (secondary recurrence) or censored at date of last contact for patients still alive and who have no progressed or recurred (from date of surgery to disease progression).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 YearsPopulation: Data was not collected due to the trial and all data collection processes being being terminated.
Overall survival will be defined as time from date of surgery to date of death or censored at the date of last documented contact for patients still alive.
Outcome measures
Outcome data not reported
Adverse Events
HIPC Treatment
Serious adverse events
| Measure |
HIPC Treatment
n=10 participants at risk
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
|
|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Pancytopenia
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
HIPC Treatment
n=10 participants at risk
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
60.0%
6/10 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
3/10 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.0%
3/10 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Acidosis
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Transaminase abnormalties
|
10.0%
1/10 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place